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| Sponsor: | NewLink Genetics Corporation |
|---|---|
| Information provided by (Responsible Party): | NewLink Genetics Corporation |
| ClinicalTrials.gov Identifier: | NCT00739609 |
Purpose
This study provides an early evaluation of an entirely new class of small molecule agents directed at disruption or elimination of tumor tolerance, a phenomenon now demonstrated to be involved in the growth of many solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Lung Cancer Melanoma Pancreatic Cancer Solid Tumors |
Drug: 1-methyl-D-tryptophan |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of 1-methyl-D-tryptophan (D-1MT) in Patients With Relapsed or Refractory Solid Tumors |
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: 1-methyl-D-tryptophan
D-1MT will be administered in escalating doses. Initial dosing will be 200 mg by mouth daily with escalation planned to 2000 mg by mouth daily and potentially higher doses in subsequent cohorts if tolerated and pharmacokinetic and biologic data support further dose escalation.
Other Name: D-1MT, NSC-721782, 1-MT
|
This protocol provides an early evaluation of an entirely new class of small molecule agents directed at disruption or elimination of tumor tolerance, a phenomenon now demonstrated to be involved in the growth of many solid tumors. D-1MT, or any other substance targeting this enzymatic pathway indoleamine-(2,3)-dioxygenase (IDO), has not been used previously in humans. Although pre-clinical toxicology in rats and dogs shows an extremely encouraging toxicity profile, the study needs to carefully evaluate the toxicities and pharmacokinetics to provide the basis for assigning a safe and biologically effective dosing regimen for later trials determining its contribution to tumor responses in phase II and III clinical trials.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Cancer Information Program 800-811-8480 cip@vanderbilt.edu | |
| Principal Investigator: Jeffrey Sosman, M.D. | |
| Study Chair: | Charles J. Link, M.D. | NewLink Genetics Corporation |
More Information
| Responsible Party: | NewLink Genetics Corporation |
| ClinicalTrials.gov Identifier: | NCT00739609 History of Changes |
| Obsolete Identifiers: | NCT00788086 |
| Other Study ID Numbers: | NLG2100 |
| Study First Received: | August 20, 2008 |
| Last Updated: | December 8, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Breast Neoplasms Lung Neoplasms Melanoma Pancreatic Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Digestive System Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Tryptophan Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |